Open To Work
Michelle Ramirez
Inizio Engage
Tampa,USA
Work Preference
Job Search Status:
Open to work
Work Type
Full Time
Location Preference
RemoteHybrid
2
Languages
11
Years of experience
Registered Nurse with 8+ years of progressive clinical, pharmaceutical, and clinical research experience, including clinical trial operations, decentralized research, protocol coordination, regulatory documentation, medical information, pharmacovigilance, patient safety, and clinical education. Clinical Research Nurse Project Coordinator experience supporting multiple research sites and collaborating with investigators, sponsors, CRAs, vendors, nurses, and clinical teams in accordance with ICH-GCP, FDA regulations, study protocols, and sponsor requirements. Experienced in reviewing and maintaining clinical and source documentation, coordinating study activities, supporting protocol adherence, training research personnel, and communicating complex clinical and regulatory information across multidisciplinary teams. Strong ability to prioritize projects, interpret clinical information, identify issues, coordinate stakeholders, and communicate clear next steps while maintaining accuracy, compliance, and data integrity.
Work History
Bilingual Virtual Clinical Educator
8 Months- Delivered bilingual clinical education to patients and caregivers participating in pharmaceutical patient support programs, applying clinical judgment and approved medical resources to support safe and appropriate therapy use.
- Educated patients on disease states, indications, mechanism of action, dosing, administration, injection techniques, storage, treatment expectations, and medication safety, enhancing understanding and adherence to prescribed therapies.
- Conducted individualized clinical consultations to assess comprehension, identify barriers, and communicate next steps, facilitating effective treatment initiation and adherence.
- Collaborated with healthcare providers, specialty pharmacies, case managers, and cross-functional teams to coordinate patient support activities and resolve issues affecting therapy initiation and continuity of care.
- Interpreted complex clinical and pharmaceutical information and translated it into concise, understandable education for patients, caregivers, and healthcare professionals.
- Collaborated with healthcare providers, specialty pharmacies, case managers, and cross-functional teams to coordinate patient support activities, resolving issues that impacted therapy initiation and continuity of care.
- Identified, documented, and escalated Adverse Events (AEs), Serious Adverse Events (SAEs), Product Quality Complaints (PQCs), and Special Situation Reports in accordance with pharmacovigilance requirements, SOPs, and regulatory standards.
- Maintained current knowledge of assigned pharmaceutical products, therapeutic areas, clinical guidelines, and approved educational materials within a regulated environment.
- Managed multiple patient interactions and competing priorities while maintaining documentation accuracy, quality standards, and established timelines.
Clinical Research Nurse Project Coordinator
1 Year 6 Months- Supported decentralized clinical trial operations across multiple research sites, coordinating clinical research activities in accordance with ICH-GCP, FDA regulations, study protocols, sponsor requirements, and applicable SOPs.
- Coordinated communications and study activities among Principal Investigators, sponsors, CRAs, vendors, nurses, and clinical research teams to ensure alignment and facilitate trial progress.
- Coordinated patient-related research activities while maintaining protocol adherence, patient safety, confidentiality, and research quality.
- Reviewed and maintained regulatory, source, and patient documentation to uphold data integrity and ensure compliance with study protocols.
- Reviewed and maintained regulatory documentation, source documentation, patient records, and study-related clinical documentation, supporting data integrity and study compliance.
- Trained nurses and site personnel on study protocols, clinical procedures, documentation expectations, and protocol requirements, reinforcing consistency and compliance across research teams.
- Communicated protocol requirements and study updates to clinical teams and stakeholders, identifying and addressing issues to minimize disruptions in study execution.
- Collaborated across multidisciplinary teams to support study milestones, accurate documentation, protocol adherence, and overall research quality.
Medical Information Specialist
2 Years- Provided medically accurate and scientifically supported responses to healthcare professionals and patients regarding pharmaceutical products, therapies, disease states, and clinical information.
- Interpreted complex medical and scientific information to provide clear, concise responses using approved resources and established procedures, enhancing understanding for healthcare professionals and patients.
- Interpreted complex medical and scientific information and communicated clear, concise responses using approved resources and established procedures.
- Collaborated with Medical Affairs, Drug Safety, Regulatory, and Quality teams to ensure compliant medical communications and timely safety escalations, supporting overall patient safety and regulatory adherence.
- Triaged, documented, and escalated Adverse Events, Product Quality Complaints, and safety information in accordance with pharmacovigilance procedures.
- Applied clinical judgment and regulatory awareness to evaluate medical information, guiding appropriate escalation and follow-up to mitigate risks and ensure safety compliance.
Psychiatric Registered Nurse
2 Years- Conducted comprehensive patient assessments, administered medications, educated on treatment plans, documented clinically, and coordinated interdisciplinary care to enhance patient outcomes.
- Managed multiple patients and competing clinical priorities in a fast-paced environment requiring sound judgment and attention to detail.
- Evaluated clinical changes and communicated relevant patient information to physicians and multidisciplinary treatment teams.
- Educated patients and families regarding medications, treatment plans, safety considerations, and continuity of care.
- Oversaw care for multiple patients and prioritized competing clinical demands in a fast-paced environment, demonstrating sound judgment and attention to detail.
- Collaborated with interdisciplinary teams to develop comprehensive mental health strategies for diverse patient populations.
- Implemented individualized care plans for patients, enhancing treatment effectiveness and patient satisfaction.
Psychiatric Registered Nurse
1 Year- Conducted nursing assessments, administered medications, documented clinical information, educated patients, and supported families for pediatric populations to ensure comprehensive care.
- Collaborated with multidisciplinary teams to address patient needs, develop treatment plans, enhance safety, and ensure continuity of care.
- Utilized clinical judgment and prioritization skills to navigate challenges in a complex behavioral health environment.
Education
Bachelor of Science - Nursing
Associate of Science - Nursing
Skills
Clinical Research Operations
Protocol implementation
Regulatory compliance
Protocol Compliance
Patient safety
Multi-site research
Study coordination
Trial documentation
Regulatory documentation
Sponsor collaboration
CRA & Site Communication
Patient Education Techniques
Patient Engagement Strategies
Medical Information
Virtual Communication Tools
English & Spanish — Fluent
Languages
English — Fluent
Spanish — Fluent
CLINICAL RESEARCH & REGULATORY EXPERTISE
- Clinical Research: Clinical Trial Operations | Decentralized Clinical Trials | Protocol Compliance | Study Coordination | Multi-Site Research | Patient Coordination | Clinical Documentation | Source Documentation | Research Staff Training | Data Quality
- Regulatory & Human Subject Protection: ICH-GCP | FDA Regulations | SOP Compliance | Regulatory Documentation | Patient Safety | Human Subject Protection Principles | Pharmacovigilance | AE/SAE Reporting | Product Quality Complaints
- Protocol & Clinical Operations: Investigator Communication | Sponsor Collaboration | CRA Communication | Site Coordination | Clinical Team Training | Timeline Management | Issue Identification | Cross-Functional Coordination | Clinical Information Review
- Pharmaceutical & Medical: Medical Information | Pharmaceutical Product Education | Disease State Education | Clinical Guidelines | Scientific Communication | Medication Safety | Patient/HCP Education
- Technology: Microsoft Office | Microsoft Word | Electronic Clinical Documentation Systems | EMR
Timeline
Bilingual Virtual Clinical Educator
Inizio Engage
11.2025 - 07.2026Read More
Clinical Research Nurse Project Coordinator
Syneos Health / Illingworth Research Group Ltd.
03.2023 - 09.2024Read More
Medical Information Specialist
Cognizant Technology Solutions
01.2020 - 01.2022Read More
Psychiatric Registered Nurse
Northwell Health Zucker Hillside Hospital
01.2017 - 01.2019Read More
Psychiatric Registered Nurse
New York City Children's Center
01.2016 - 01.2017Read More
Hillsborough Community College
Associate of Science from Nursing
Read More
The University of Texas at Arlington
Bachelor of Science from Nursing
Read More